The much-anticipated amendment regarding the extension of the MDR transitional periods and the removal of the sell-off dates of both MDR and IVDR has entered into force as of 20th March 2023. The amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the limited capacity of the notified bodies.
Advena has created a guidance document that will help you understand this new extension. The document explains the amendment in a very clear and concise way, incorporating flowcharts, timelines and a Q&A section to help you navigate through the intricacies of this new amendment.
The guidance document can be accessed using the link below;
